Following the news that the European Commission have approved Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) and low-dose Yervoy (ipilimumab) for previously untreated intermediate- or poor-risk advanced renal cell carcinoma,
Chloé Thépaut, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the company’s position:
‘‘The approval of BMS’ in-house IO combination, based on results from the Phase III CheckMate-214 trial is the first of its kind for Europe in this setting. GlobalData identifies that combination therapy is a key trend, representing the future in immuno-oncology. This means BMS is making the right moves to secure and maintain a strong presence in the field.
“Data from CheckMate-214 was promising, with the study stopped early as the combination significantly improved overall survival versus current standard of care, Pfizer’s Sutent (sunitinib) monotherapy. In addition, overall survival benefit was consistent, regardless of PD-L1 expression levels. Opdivo + low dose Yervoy was already approved in the US in this indication, and the European approval represents a significant step towards the combination becoming standard of care in multiple markets.
“In the recent weeks, BMS has been reminding the world that it is a strong contender in the immuno-oncology space, despite being apparent runner-up behind Merck at the end of 2018. The company announced its plans to acquire Celgene in the first week of January 2019, instantly becoming one of the leading franchises in immuno-oncology, with two approved checkpoint inhibitors, and four late-stage chimeric antigen receptor (CAR) cell therapies.
“BMS’ strong pipeline and ever-growing list of indications for lead checkpoint inhibitor Opdivo, demonstrates the company’s huge potential for success in the highly crowded market of immuno-oncology, with its agents covering a wide range of indications, and going for first-in-class status, such as the European approval of Opdivo + low dose Yervoy for untreated RCC.”